REGULATORY INTELLIGENCE YEAR-END REPORT - 2022 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Cost Savings This Issue Brief was written by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/19/2022 I. Introduction Nevada Governor Steve Sisolak recently announced that the state has officially launched ArrayRx, a free digital discount card for prescription drugs available statewide for all residents. Florida Governor Ron DeSantis recently announced a lawsuit against the U.S. Food and Drug Administration in response to their 'unreasonable delay" of more than 630 days in approving Florida's proposal for its Canadian Prescription Drug Importation Program. AllianceRx Walgreens Pharmacy regularly performs clinical audits on its specialty claims. In 2021, the company realized $6.2 million in annualized savings through its dose optimization program, leading to an average savings of $6,173 per optimized dispense. Pennsylvania's Capital Blue Cross will become the first health plan in the nation to collaborate with the Mark Cuban Cost Plus Drug Company in an attempt to help bring high-quality, lower-cost prescription drugs to its members as well as the communities it serves. Arine, a medication intelligence company, and Gemini Health LLC, a drug cost transparency platform, recently announced an integration of the two companies' platforms to 'optimize value-based care" for members of Blue Shield of California (Blue Shield). McKesson Corporation recently announced that it has signed a definitive agreement to acquire Rx Savings Solutions, a prescription price transparency and benefit insight company that offers 'affordability and adherence solutions" to health plans and employers, reaching more than 17 million current patients. In April 2020, Eli Lilly and Company introduced the Lilly Insulin Value Program $35 copay card, which was intended to help people struggling financially during the COVID-19 crisis. The company has now recently announced that the program has been added to the company's comprehensive suite of insulin affordability solutions. ll. General Cost Saving News Mark Cuban Drug Company Launches Website Offering Discount Prescription Drugs Mark Cuban Cost Plus Drug Company (MCCPDC) recently officially launched its online pharmacy at www.costplusdrugs.com. The launch occurs weeks after their pharmacy benefit manager (PBM) operation was established at www.costpluspbm.com. According to the company, both projects are 'critical efforts in the company's pursuit to help shield consumers from inflated drug prices." According to a September 2021 Gallup poll, 18 million Americans were recently unable to pay for at least one prescription medication for their household due to rising prescription drug costs, and 1 in 10 Americans have skipped doses to save money. The pharmacy's launch, according to a press release, 'represents the first critical milestone in bringing affordable medications to millions." Notable medications offered by the pharmacy include: Imatinib - leukemia treatment Retail price: $9,657 per month Lowest price with common voucher: $120 per month MCCPDC price: $47 per month THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Mesalamine - ulcerative colitis treatment Retail price: $940 per month Lowest price with common voucher: $102 per month MCCPDC price: $32.40 per month Colchicine - gout treatment Retail price: $182 per month Lowest price with common voucher: $32 per month MCCPDC price: $8.70 per month Alex Oshmyansky, CEO of Mark Cuban Cost Plus Drug, stated that, 'We will do whatever it takes to get affordable pharmaceuticals to patients.' Mr. Oshmyansky also noted that, 'The markup on potentially lifesaving drugs that people depend on is a problem that can't be ignored. It is imperative that we take action and help expand access to these medications for those who need them most.' As a registered pharmaceutical wholesaler, MCCPDC can bypass middlemen and markups that it characterizes as 'outrageous." The pharmacy's prices reflect actual manufacturer prices plus a flat 15% margin and pharmacist fee. With the assistance of digital healthcare company Truepill, the company hopes that patients will experience a seamless, secure e- commerce experience as they navigate the pharmacy's website. The website is built and powered by Truepill's digital health platform. Prescription fulfillment and delivery will occur through Truepill's nationwide pharmacy footprint. Because the company refuses to pay spread prices to third-party PBMs in order to be allowed to process insurance claims, the online pharmacy will be a cash pay venture. However, its model allows patients to immediately purchase a broad array of medications at prices often less than what most insurance plans' deductible and copay requirements would total. In November 2021 MCCPDC entered the PBM industry to serve companies providing prescription coverage in their employee benefit plans. MCCPDC has pledged to be 'radically transparent' in its own negotiations with drug companies as a PBM, revealing the true costs it pays for drugs and eliminating spread pricing and misaligned rebate incentives. MCCPDC anticipates that its PBM could save companies millions of dollars with no changes to its benefits, depending on the size of the employer, because it will eliminate the traditional PBM model. The company also plans to integrate its pharmacy and wholesaler with its PBM, so any company that uses its PBM will have access to wholesale pricing through its online pharmacy. Mr. Oshmyansky further stated that, 'There are numerous bad actors in the pharmaceutical supply chain preventing patients from getting affordable medicines. The only way to ensure affordable prices get through is to vertically integrate.' The Mark Cuban Cost Plus Drug Company 'aims to fundamentally change the way the pharmaceutical industry operates." As a public- benefit corporation, it states that its social mission of improving public health is just as important as the bottom line. The company transparently charges a standard markup on every drug it sells. Based on the launch of its online pharmacy's first inventory of 100 affordable generic drugs in January 2022, its establishment as a vertically integrated pharmacy benefits manager, and the construction of a state-of-the-art pharmaceutical factory in Dallas predicted for completion by the end of 2022, the company states that it intends to make medications affordable for all. FN2! Report Finds 85% Of Patients Had To Make Financial Sacrifices To Afford Prescriptions Over Last Year New data recently released by CoverMyMeds found that 82% of patients experienced medication delays in the last year due to COVID-19 restrictions, insurance processes, communication challenges, and prescription cost. Of those patients who experienced medication delays, 85% of them had to make financial sacrifices to afford their prescriptions. In addition to medication delays, many patients also postponed medical visits in the past year. According to the 2022 Medication Access Report, 84% of patients delayed or skipped in-person healthcare visits, mostly due to COVID-19 fears or a scarcity of appointments, contributing to an estimated 500 million missed diagnostic visits and more than 15 million fewer new prescriptions. The 2022 Medication Access Report uses industry research, patient interviews, and new survey data from patients, pharmacists, providers, payers and biopharma companies to identify opportunities for healthcare technology to improve medication access. Additional key findings in this year's report include: Other findings of the report include: ¢ 79% of patients said they've gone to the pharmacy only to discover a prescription cost more than they expected. Nearly 31% of those patients left without their medication or did not seek affordability options. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ When faced with an affordability challenge, 56% of patients attempted to stretch out a prescription, 52% of patients skipped bills or other essential items to afford medications, and 51% of patients sacrificed medications to pay bills and other essentials. The report also concluded that care teams in every setting are affected by pandemic stress: ¢ 54% of pharmacists said they lack time to complete their job effectively, with 81% citing inadequate staffing and 73% citing time- consuming administrative tasks. ¢ Physicians also felt strained by demands, with 42% reporting burnout and 69% feeling depressed. The report suggested that, 'timely, actionable data is needed across the healthcare ecosystem to improve patient care:" ¢ To better inform affordability conversations with patients and help patients start specialty therapies, 56% of providers6 and 63% of pharmacists said they need access to patient-specific benefit information. * Approximately 25% of providers6 and 36% of pharmacists said they have in-workflow access to critical information, such as plan- and pharmacy-specific pricing, cash pricing and patient deductible data needed to effectively support patients on their medication access journeys. The 2022 Medication Access Report also highlights technology solutions that automate historically manual processes and provide actionable information that better enable care team members to help patients get the medicine they need. John Beardsley, senior vice president of corporate strategy at CoverMyMeds, commented on the findings of the report, noting that, 'For decades, the U.S. healthcare industry has wrestled with utilizing technology and timely insights to address quality, cost, choice and convenience to create better patient outcomes.' Mr. Beardsley also stated that, 'But in the last two years, we have witnessed new digital health solutions emerge to meet the heightened needs from care teams and patients. By adopting newfound workflows and the latest technology to navigate patient care, the industry can further improve healthcare interoperability and progress toward the vision of improved outcomes.' The report is published by CoverMyMeds, part of McKesson Corporation, with an advisory board of industry leaders from Albertsons Companies, California Chronic Care Coalition, Cambia Health, Cerner, Clearview Healthcare Partners, Community Health Network, eMDs, Horizon Government Affairs, National Council for Prescription Drug Programs, National Patient Advocate Foundation, The Ohio State University Wexner Medical Center, Ontada, Orsini Healthcare and PioneerRx. Information used to compile the report was taken from the following sources: CoverMyMeds Patient Survey, 2021; IQVIA Institute Digital Health Trends, 2021; IQVIA Medical Claims Data Analysis, 2021: CoverMyMeds Pharmacist Survey, 2021; Medscape National Physician Burnout & Suicide Report, 2021; and CoverMyMeds Provider Survey, 2021. CoverMyMeds is a medication access company 'committed to helping people get the medicine they need to live healthier lives." [FN3] Study Finds Drug Spending Per Covered Member Grew Faster In Individual Health Plans Compared To Large Group Plans A recent study found that prescription drug spending per member covered (both before and after manufacturer rebates) rose much faster for those enrolled in individual health insurance plans compared to those enrolled in large group plans during the period of 2015 to 2109. The study, which was published in JAMA Health Forum by researchers at Johns Hopkins University and Texas Christian University, is the first study to examine prescription drug spending at the commercial insurance plan level. Researchers involved in the study examined pre-rebate and post-rebate annual drug spending per covered member (inflation-adjusted) over the five-year period, separately by plan type. For large group plans, post-rebate drug spending per covered life grew annually by approximately two percent on average despite many new therapies being marketed. Post-rebate drug spending per covered life grew annually by approximately 11 percent on average for individual plans. According to Professor Ge Bai, professor of practice at Johns Hopkins Carey Business School, 'Our study identified an overlooked health equity issue in health insurance for those with individual coverage plans. Unsubsidized Americans enrolled in individual plans do not have the same access to more affordable prescription drug plans as enrollees in large group plans." Bai also noted that, 'Since the implementation of the Affordable Care Act in 2014, prescription drug plans for the individual insurance market have become increasingly unaffordable for Americans not eligible for federal subsidies. This widening gap in affordability between individual plans and large group plans is attributable to regulatory constraints on the individual market and deteriorating risk pools." Bai's research focuses on pricing, policy, and management within the health care industry. In 2015, the post-rebate drug spending per covered life on prescription drugs was six percent lower in individual plans ($644) than in large group plans ($686). In 2019, this figure was 35 percent higher in individual plans ($995) than in large group plans ($738). Pre-rebate spending had a similar trend. Higher pre-rebate spending indicates higher patient out-of-pocket costs, and higher post- rebate spending often reflects higher insurance premiums. In the meantime, enrollment in individual prescription drug plans dropped by 24 percent from 16.1 million to 12.3 million. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. The data in the study were from the health insurers' mandatory medical loss ratio (MLR) filings for 2015 through 2019, for each state separately and for the individual, small group, and large group markets in each state. The sample includes approximately 2,200 unique health plans (70 million covered lives per year) with reported positive prescription drug prices. The research was supported by Arnold Ventures, a private investment fund that specializes in health care, education, criminal justice, and public finance. Ge Bai is a visiting scholar at the Congressional Budget Office. [FINA] Study Finds 7.7% Increase In U.S. Pharmaceutical Spending In 2021; Predicts 4-6% Increase in 2022 A recently published study in the American Journal of Health-System Pharmacy found that, in 2021, overall pharmaceutical expenditures in the United States increased by 7.7% compared to 2020, totaling $576.9 billion in spending. Utilization (a 4.8% increase), price (a 1.9% increase), and new drugs (a 1.1% increase) drove this increase. Adalimumab was the top drug in overall expenditures in 2021, followed by apixaban and dulaglutide. Drug expenditures were $39.6 billion (a 8.4% increase) and $105.0 billion (a 7.7% increase) in nonfederal hospitals and in clinics, respectively. In clinics and hospitals, new products and increased utilization growth were the primary growth drivers, with decreasing prices for both sectors acting as an expense restraint. Several new drugs that are likely to influence spending are expected to be approved in 2022. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. The researchers involved in the study predicted that, overall prescription drug spending will rise by 4.0% to 6.0% in 2022. This increase in clinics and hospitals is predicted to be approximately 7.0% to 9.0% and 3.0% to 5.0%, respectively, compared to 2021. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of several local factors that can influence actual spending. Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Researchers reviewed factors that may influence drug spending in hospitals and clinics in 2022. These include new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, COVID-19 pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2022 were based on a combination of quantitative analyses and expert opinion. [FNS] RazorMetrics Survey Finds That Most People Prefer Their Doctor To Choose Lowest Cost Drugs For Them RazorMetrics, a healthcare technology company, recently conducted a consumer opinion survey regarding drug costs and found that healthcare consumers prefer that their physician take the lead on lowering drug costs. The survey found that 80% of respondents would prefer their physician be the one to choose a lower-cost drug for their prescription and do so automatically. RazorMetrics' drug cost survey asked, 'if a prescription is too expensive what do you do?" Approximately 9.3% of survey respondents said they 'Forget about it and go home." Other responses included 'Pay for it anyway" (22.3%), 'Ask the pharmacist about a discount" (35.3%), 'Call my doctor" (21.7%), and 'Call my insurance company' (11.3%). Seventy-two percent of survey respondents said that their physician talks to them about drug prices and generics. A problem, however, is that physicians often cannot estimate the cost of medication due to a lack of data intelligence: when writing a prescription, physicians often do not know what the cost will be to the patient. 'As a cardiologist with an active practice, | can attest to the frustration doctors feel when we get a call from a patient at the pharmacy. We try another medication hoping that it will be covered by the patient's health plan. The system is built on a trial by error model," said Dr. Siva Mohan, MD, and co-founder of RazorMetrics. 'It's inefficient and deeply frustrating for everyone involved." Among those surveyed by RazorMetrics, 69% said they would be open to trying mail order pharmacy. Dr. Mohan noted that, 'The trick is making the change to mail order easy and ensuring the pharmacy is demonstrably less expensive. RazorMetrics' has the ability to communicate this information to the physician, who then can feel comfortable making the recommendation to the patient." Sixty-seven percent of RazorMetrics' survey respondents reported using a discount card at least once. Discount cards could help the 49% of Americans that use at least one prescription medication every month. The most popular company among survey respondents was GoodRx by a large margin (56.5%). Pharmacy Supplied Discount (16.5%) and Amazon Prime Rx (19%) were the next popular. OptumRx Perks (2%), SingleCare (5.5%), and ScriptSave Well Rx (0.5%) were less represented among the survey pool. [FN6] Study Finds Legalization Of Recreational Marijuana Reduces Need For Costly Prescriptions In Medicaid Programs A study conducted by Cornell and Indiana researchers suggests that the legalization of recreational marijuana reduces demand for costly prescription drugs through state Medicaid programs. The researchers found that, when states legalize marijuana, the volume of prescriptions within the drug classes that align with the medical indications for pain, depression, anxiety, sleep, psychosis, and seizures significantly decline. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Shyam Raman, a doctoral student in the Cornell Jeb E. Brooks School of Public Policy, and Indiana University doctoral student Ashley Bradford conducted the research. Their article, titled 'Recreational Cannabis Legalizations Associated with Reductions in Prescription Drug Utilizations Among Medicaid Enrollees," was published on April 15, 2020 in the journal Health Economics. Raman and Bradford analyzed data retrieved from the Centers for Medicare and Medicaid Services in all 50 states from 2011 to 2019, a period that experienced growth in the number of states allowing personal use of marijuana. Most past cannabis research has focused on the impact of medical marijuana on demand for prescription drugs or the impact of recreational use legalization on opioid demand. This study is one of the first studies to focus its attention on the impact of legal personal-use cannabis on a broad range of prescription drugs. According to Raman, 'These results have important implications. The reductions in drug utilization that we find could lead to significant cost savings for state Medicaid programs. The results also indicate an opportunity to reduce the harm that can come with the dangerous side effects associated with some prescription drugs." Approximately 40 states have legalized medical marijuana that must be prescribed by a doctor, and approximately 20 states have legalized personal-use cannabis for all adults. In those 20 states, Raman and Bradford found a meaningful change in the demand for drugs used to treat sleep and anxiety disorders, but no meaningful impact on drugs used to treat nausea. Raman and Bradford caution that cannabis use is not necessarily harmless, noting the many studies that associate it with a potential triggering of anxiety and psychoses (such as schizophrenia). Furthermore, patients who use marijuana to treat their medical conditions may then avoid visiting their doctor, which could lead to unintended consequences. [FN7] Colorado Announces Partnerships To Assist With Canada Drug Importation Program The Colorado Governor's office and the Colorado Department of Health Care Policy & Financing (Department) recently announced partnerships that are intended to help Colorado operationalize the importation of lower cost medications from Canada to save citizens money, while also ensuring the health and safety of Coloradans. Colorado's Canadian Importation Program, once approved by the Food and Drug Administration (FDA), is predicted to save consumers and employers an average of more than 60% on prescription medications. 'Saving people money and lowering health care costs has been a top priority of our administration since day one, and now we have a major piece in place to make drugs more affordable. Colorado's Drug Importation Program is an important step to lowering the cost of prescription drugs and keeping more money in people's pockets," said Colorado Governor Jared Polis. '| am proud to see the progress of the program and the steps forward in making lower health care costs a reality across Colorado and look forward to delivering real results and savings." In 2019, Governor Polis signed the bipartisan SB19-005, which authorized the Department to seek approval from the federal government to establish an importation program that will provide access to Canada's lower priced drugs to Colorado employers and consumers. In 2021, Governor Polis signed the bipartisan SB21-123, which authorized the Department to expand Drug Importation to other trade partner countries, if federal law is amended to allow this. The Department conducted an in-depth analysis of Colorado drug prices versus those in other countries, finding that expanding importation to other countries, like France or Australia, could deliver even higher savings (such as 84% and 78%, respectively). '| know firsthand the burden and stress high health care costs can place on families across our state, which is why | am so excited to see this big step forward in making the cost of prescription drugs more affordable and accessible through the Colorado Canadian Drug Importation Program," said Lieutenant Governor Dianne Primavera and the Director of the Office of Saving People Money on Health Care. 'The Polis-Primavera administration and The Office of Saving People Money on Health Care are committed to creating new innovative ways to ensure all Coloradans have access to high quality and affordable health care." All three partners, together with the state, will contribute to Colorado's Drug Importation program: ¢ AdiraMedica LLC, a U.S. wholesaler and their subsidiary located in Ontario, Canada will fulfill the role of Colorado's foreign seller, which serves as the primary conduit with Canadian manufacturers. They will purchase the products for Colorado's program and ensure they meet specifications for exportation to the United States. ¢ Premier Pharmaceuticals LLC is a U.S. wholesaler located in Boise, Idaho and will serve as Colorado's importer. They will be the primary distributor once medications come into the U.S. and will sell the medications to participating Colorado pharmacies. Additionally, Premier manages key aspects of the program, including partnering with a qualified laboratory and re-labeler to ready products for the Colorado market. * Denver's Rocky Mountain Poison and Drug Safety will be responsible for all FDA required adverse event reporting as well as respond to consumer inquiries. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. The Department of Health Care Policy & Financing released a report outlining solutions to high prescription prices facing many Colorado residents and their families. Colorado is advancing Canadian importation as one of these solutions to bring meaningful relief to Coloradans. Coloradans and their employers are paying much more for the same prescription drugs than their Canadian counterparts. Drug Importation from Canada is intended to allow Colorado consumers and employers to pay a 'fair' price for their medications. 'If you look closely at the labels on your prescription drugs in your medicine cabinet, you will find many prescriptions are already manufactured in other countries," said Kim Bimestefer, executive director of the Department. 'Our Canadian Drug Importation program will not only reduce the cost of prescription drugs to the benefit of Coloradans and our employers, but will do so safely and in compliance with all federal safety guidelines." The FDA suggests that 78% of active pharmaceutical ingredient manufacturers are located outside of the United States. All drugs imported through the program will be subject to additional testing for authenticity and degradation. Importation of certain prescription drugs was made possible through a change in federal policy in November 2020. The federal final rule implements a provision of federal law from 2003 that allows FDA-authorized programs to import certain prescription drugs from Canada to Colorado. Colorado is one of several states implementing state-led importation programs. The Department is finalizing the state's importation application for submission to the FDA in the fall of 2022. [FN8] Nevada Announces Launch Of Free Digital Discount Card ArrayRx Nevada Governor Steve Sisolak recently announced that the state has officially launched ArrayRx, a free digital discount card for prescription drugs available statewide for all residents. Nevadans can now sign up online at ArrayRxCard.com to receive their digital card and save up to 80% on certain medications. 'Prescription medications can get very expensive ? too expensive. This program will help Nevadans keep more money in their pockets," said Governor Sisolak. "Taking care of yourself and prioritizing your health shouldn't leave you bankrupt ? and | will never stop in my mission to bring more affordable health care solutions to Nevadans. I'm so proud of the commitment across our State to get this program up and running, as well as our interstate partnerships all dedicated to addressing high drug costs." During the Governor's State of the State address in February, he announced that Nevada would be joining Oregon and Washington to reduce prescription drug costs through the implementation of a statewide drug discount card. 'This is a team effort, and it really does take a community to be able to deliver to the folks we represent and to make sure that people can live here, work here and raise their families here," said Senator Majority Leader Nicole Cannizzaro. 'This ArrayRX digital card is another tool in our toolbox to ensure that Nevadans can continue to afford the healthcare they need and to take care of their families." 'We hope this free, easy to join program will be a benefit to Nevadans," said Beth Slamowitz, PharmD, Senior Policy Advisor on Pharmacy for the Nevada Department of Health and Human Services. 'All FDA-approved prescriptions are eligible for discounts, and we encourage families to enroll every member for maximum savings. All Nevadans are eligible to join, but each must have their own digital ArrayRx Discount Card." Under the ArrayRx program, all Nevadans are eligible to enroll, regardless of age, income, or citizenship. [FNS] Capital Blue Cross Partners With Mark Cuban Cost Plus Drug Company Pennsylvania's Capital Blue Cross will become the first health plan in the nation to collaborate with the Mark Cuban Cost Plus Drug Company in an attempt to help bring high-quality, lower-cost prescription drugs to its members as well as the communities it serves. Cost Plus Drugs, which was launched earlier this year by Mark Cuban, charges consumers 15% more than it pays to buy a drug from the manufacturer, along with a $3 per-prescription dispensing fee and shipping. As a result, consumers can experience savings of up to 80% on some of the most commonly prescribed generic drugs. For example, atorvastatin, a commonly used cholesterol lowering medication, costs approximately $4 per month through Cost Plus Drugs and can cost significantly more at retail. Capital Blue Cross President and CEO Todd Shamash said the relationship with Cost Plus Drugs is important to Capital's members and the communities the insurer serves. Shamash noted that, 'Capital's collaboration with Cost Plus Drugs will help us bring lower-cost medications to members and nonmembers alike across our service area, providing some much-needed relief to those struggling to pay for their vital ? and sometimes life-saving ? medications." He further stated that, 'We are passionately committed to finding new ways, new relationships that help us improve affordability in healthcare." Dr. Alex Oshmyansky, CEO of Mark Cuban Cost Plus Drug Company, also commented on the partnership. He stated that, 'Our mission at Cost Plus Drugs is to ensure all consumers have access to the medications they need to be healthy ? a goal Capital Blue Cross shares. Working with a like-minded organization like Capital gives us more momentum to help people get the medications they need at costs they can afford." THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. According to a September 2021 Gallup poll, 18 million Americans have been unable to afford at least one prescription medication for their household, and 1 in 10 Americans have skipped doses to save money. Both Capital Blue Cross and Cost Plus Drugs claim that they are dedicated to helping lower prescription drug costs to consumers so they don't have to skip needed medications. This month, Capital Blue Cross and Cost Plus Drugs will begin sharing information about their collaboration with Capital members and community organizations to explain how they can access the availability of low-cost drugs. In 2023, Capital Blue Cross members will be able to use their insurance cards at Cost Plus Drugs. Capital Blue Cross serves a 21-county region in Central Pennsylvania and the Lehigh Valley by offering health insurance products, services, and technology solutions. The Mark Cuban Cost Plus Drug Company, PBC is a public-benefit corporation with a social mission of improving public health. [FN10} AllianceRx Walgreens Pharmacy Claims To Save $6.2 Million Yearly From Dose Optimization Program AllianceRx Walgreens Pharmacy regularly performs clinical audits on its specialty claims. In 2021, the company realized $6.2 million in annualized savings through its dose optimization program, leading to an average savings of $6,173 per optimized dispense. Specialty drugs now account for 50% or greater of the total amount spent on prescription drugs. In some cases, employers' specialty costs account for 60% or even greater of their total drug spending. 'As more specialty medications come to market and are prescribed, innovative strategies like our clinical audit programs will be needed to help mitigate the increasing costs," says William Trombatt, PharmD, CSP, manager of clinical programs at AllianceRx Walgreens Pharmacy. Dose optimization is a clinical audit program designed to directly decrease medication costs. This strategy minimizes the number of units (oral, injectable, or infused) dispensed for a prescription while providing the same appropriate dose to the patient. For example, some pharmaceutical manufacturers may charge similar prices for 5- and 10-mg capsules. If a physician writes a prescription for two 5- mg capsules each day, this prescription can be more efficiently and economically dispensed with one 10-mg capsule.2 In 2021, the clinical audit team at AllianceRx Walgreens Pharmacy identified and reviewed approximately 300 individual patient cases. 'After review, 37% of the cases were determined to be a non-opportunity ? mainly due to negative financial impact to the patient, medication discontinuation or dose change. Thirty percent of the cases were successfully intervened upon resulting in an annualized savings of over $6.2 million. In 33% of the cases, the prescriber failed to respond to or declined our request," Trombatt noted. Trombatt further stated that, 'With this program, we are striving to help patients reduce the number of tablets or capsules they must take and decrease overall prescription costs. This program minimizes the number of units dispensed for a prescription while providing the appropriate dose to the patient." [FN11] Arine And Gemini Health Integrate Platforms For Blue Shield of California Members Arine, a medication intelligence company, and Gemini Health LLC, a drug cost transparency platform, recently announced an integration of the two companies' platforms to 'optimize value-based care" for members of Blue Shield of California (Blue Shield). The collaborative effort will allegedly bolster the ability of Blue Shield's care team and affiliated pharmacist provider network to coach and counsel Blue Shield members with real-time and accurate medication recommendations and related cost information. This integration is designed to help members take and stay on the right medications while minimizing out-of-pocket expenditures. 'The medical evidence demonstrates that higher out-of-pocket medication costs, suboptimal drug choice and dosages, and medication non-adherence are associated with more medical visits, hospitalizations, and other adverse events,' said Salina Wong, PharmD, senior director of Clinical Pharmacy Programs at Blue Shield of California. Wong further noted that, 'Blue Shield of California is committed to creating a healthcare system that is sustainably affordable, and the integration between Arine and Gemini provides pharmacy care teams with medication insights and cost transparency information that empower them to provide highly personalized medication consultations with each member. This new process is a major leap from looking up a static formulary and helps support us in reaching our goals.' The Arine-Gemini collaboration incorporates Gemini's real-time, patient-specific benefits data into the Arine platform, which generates recommendations for targeted and personalized medication interventions. The integration of the two companies' platforms is intended to enable safe and effective therapy at the lowest available costs. 'We are thrilled to collaborate with Gemini to help Blue Shield of California deliver affordable, accessible, and high-quality health care, said Yoona Kim, PharmD, PhD, Arine's co-founder and CEO. 'Combining our complementary services allows Blue Shield care teams to provide members with data-driven recommendations that resolve medication gaps while potentially lowering member out-of-pocket costs.' Ed Fotsch, Gemini Health CEO, stated that, 'We see great synergies between Arine's medication intelligence and our real-time benefits capabilities to materially improve cost and quality medication outcomes in a reproducible and scalable manner,' commented Ed THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Fotsch, Gemini Health CEO. 'The integrated offering will help Blue Shield of California reach the next level of personalized medication management for its members.' As of now, more than a third of members identified as non-adherent have benefited from tailored interventions to improve adherence with cost savings alternatives. Arine is a next-generation medication intelligence company. Arine's platform helps customers devise appropriate, just-in-time interventions to optimize medication management for their patients or members. Gemini Health LLC delivers Drug Cost Transparency Services to providers and members to reduce drug and administrative costs for patients, providers, and payers. The four Gemini Drug-Cost Transparency Services focus on new and existing medications and deliver decision support for busy providers and pharmacists integrated into their workflows, including actual patient-specific costs of drugs, lower-cost clinically equivalent alternative drugs and lower-cost pharmacies when applicable. The alternatives and costs are based upon the patient's pharmacy benefit and related health plan coverage details. [FN 12] McKesson Acquires Rx Savings Solutions McKesson Corporation recently announced that it has signed a definitive agreement to acquire Rx Savings Solutions (RxSS), a prescription price transparency and benefit insight company that offers 'affordability and adherence solutions" to health plans and employers, reaching more than 17 million current patients. The transaction is valued up to $875 million, which includes a $600 million upfront payment and a maximum of $275 million of consideration contingent upon RxSS' financial performance through calendar year 2025. The transaction is subject to customary closing conditions, including regulatory review, and is expected to close in the second half of Fiscal 2023. "Rx Savings Solutions' offerings for employers and patients will strengthen McKesson's ability to help solve the most common medication challenges related to access, affordability and adherence," said Brian Tyler, chief executive officer, McKesson. 'We expect the acquisition of Rx Savings Solutions to accelerate McKesson's growth priority in biopharma services by extending our ecosystem of differentiated medication access solutions to patients. Together with Rx Savings Solutions, McKesson will amplify our efforts to advance health outcomes for all." 'This combination brings together two highly complementary organizations with closely aligned goals and values. By joining McKesson, we will be able to offer an exceptionally broad set of services to our clients and strengthen our leadership in prescription price transparency," said Michael Rea, a clinical pharmacist who founded and currently leads Rx Savings Solutions. 'This is a critical part of our growth journey, and we are excited about what the future holds for Rx Savings Solutions as part of McKesson." RxSS contracts directly with health plans and large self-funded employers to maximize the effectiveness of benefit design to drive prescription cost savings for members. The company uses an evidence-based, proprietary machine-learming algorithm to help members understand available options for therapy and identify cost-effective prescription alternatives under their insurance. If a prescription change would benefit the member, RxSS provides assistance to update the prescription. The company also provides ongoing medication reminders to help improve adherence. Following the closing of the transaction, RxSS will become part of the company's Prescription Technology Solutions business, which works across the healthcare delivery system to offer next-generation patient access, affordability and adherence solutions. The combined organization will 'endeavor to bring new capabilities for employers and patients to McKesson's broad portfolio of pharmacy, provider, payer, and biopharma services." After initial integration, McKesson expects to use the combined medication access, affordability, and adherence services as a foundation to build new outcomes management programs for biopharma and payers, differentiated by their reach and efficacy at three touchpoints: provider office, pharmacy counter, and direct patient tools. McKesson Corporation is a diversified healthcare services company 'dedicated to advancing health outcomes for patients everywhere." Rx Savings Solutions helps members and payers reduce prescription drug costs through a combination of clinical technology, transparency, member engagement and concierge support. [FN13] Eli Lilly Extends Insulin Value Program Offering $35 Copays For Anyone With Commercial Or No Insurance In April 2020, Eli Lilly and Company introduced the Lilly Insulin Value Program $35 copay card, which was intended to help people struggling financially during the COVID-19 crisis. The company has now recently announced that the program has been added to the company's comprehensive suite of insulin affordability solutions. Therefore, anyone with commercial insurance, and those without insurance at all, can continue filling their monthly prescription of Lilly insulins for $35 through this program. The copay card is being added to Lilly's suite of options aimed to help people with high-deductible insurance plans who otherwise face challenging out-of-pocket costs and those who don't have insurance because of their income or job status. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. 'No one should ever have to ration their insulin. That's why we are committed to including the copay card in our ongoing suite of solutions,' said Mike Mason, president, Lilly Diabetes. 'Making insulin affordable at pharmacies through programs like the Lilly Insulin Value Program helps reduce the financial burden some people face at the pharmacy counter.' The copay card can be accessed immediately through the Lilly Diabetes Solution Center. Several of the companies' programs, such as help for people with immediate needs, automatic caps at retail pharmacies, and donations to nonprofit organizations such as Lilly Cares assist up to 20,000 people each month access Lilly insulins at lower costs. The $35 copay card can be accessed by calling a phone number or by downloading the copay card at insulinaffordability.com. Previously this year, Lilly announced plans to make its insulins available through the Medicare Part D Senior Savings Model, allowing seniors to purchase their monthly prescriptions for $35. Both the Lilly Insulin Value Program and Medicare Part D Senior Savings Model provide options for anyone using Lilly insulin to purchase their monthly prescription at retail pharmacies for $35 starting in January 2021. 'Shifting costs from healthy people to those with chronic conditions such as diabetes is a persistent trend that must be reversed,' Mason said. 'The Part D Senior Savings Model is a solution-oriented approach to a problem that has affected seniors for a long time. This program will help people living with diabetes who use insulin.' Lilly also provides penny-priced insulin to all 340B covered entities. Additionally, following the Biden Administration's recent executive order requiring Federally Qualified Health Centers to pass 340B discount pricing for insulin onto patients, Lilly also recently announced that it will continue selling insulin at 340B prices to only those contract pharmacies that agree to pass discounts onto patients with no mark-ups, dispensing fees or duplicate billing. The recent announcement relating to insulin is associated with the start of a new awareness program launched by Lilly. Throughout the program, called 'Insulin Affordability: Leam, Act, Share," Lilly plans to collaborate with several national, state and local organizations to educate people using Lilly insulin how to take action and save money at the pharmacy. 'We've launched this awareness initiative as part of our ongoing commitment to help people using Lilly insulin access it at an affordable out-of-pocket cost,' said Adrienne Brown, vice president, U.S. Connected Care & Insulins. 'Although we offer several affordability programs, we know there are people who have not taken action to get help. Our goal is to encourage people who use Lilly insulin and need help to take actions that may lower their out-of-pocket costs at the pharmacy.' 'Everyone in the health care community must work together to help patients understand their options if they use insulin,' noted Elena Rios, M.D., President and CEO of the National Hispanic Medical Association. 'Too many people continue to face high costs because they don't have insurance, or because they have inadequate insurance. Making our communities aware of the $35 copay card and other programs available ? and how to access them ? will help ensure people can afford their insulin.' Furthermore, a separate copay card for Humulin? R U-500 (insulin human injection, 500 units/mL) allows for a monthly prescription fill for as little as $25 for people with commercial insurance and can be accessed at Humulin.com. Also, people with commercial insurance who use Bagsimi? (glucagon) nasal powder 3 mg can pay as little as $25 for up to two devices with a copay card, which was first made available in August 2019. Lilly copay cards are not available to patients with government insurance such as Medicaid, Medicare, Medicare Part D, TRICARE?/ CHAMPUS, Medigap, DoD, or any State Patient or Pharmaceutical Assistance Program. IFN14] Ill. Legislation, Regulation, And Legal Actions Biden Administration Announces New Rules Requiring Transparency In Prescription Drug Costs The Biden Administration recently announced additional rules intended to reduce health care costs by requiring health insurance issuers, employer-based health plans, and other group health plans to report on prescription drug and health coverage costs. The requirement is being implemented through an interim final rule with request for comments issued by the Departments of Health and Human Services (HHS), Labor, the Treasury, and the Office of Personnel Management. The action requires health plans, health insurance issuers offering group or individual health insurance coverage, and health benefits plans offered to federal employees to submit key data to the Departments, which will work through the HHS Assistant Secretary for Planning and Evaluation (ASPE) to publish a report on prescription drug pricing trends and rebates, as well as their impact on premiums and consumers' out-of-pocket costs. The data submission requirements include information on average monthly premiums and drug spending for patients, compared to their employers and/or group health plans/health insurance issuers. Since prescription drugs account for a significant portion of health care spending for consumers, plans, issuers, and the government, the interim final rule also implements unique requirements to identify specific cost drivers. Plans and issuers must now provide the Departments with an annual overview of their top 50 drugs across key areas of concern, including: ¢ the most frequently dispensed brand prescription drugs, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ the costliest prescription drugs, and ¢ the prescription drugs that had the greatest increase in total annual plan spending over the previous year. Additional information on prescription drug rebates, fees, and other remunerations paid by drug manufacturers to plans, issuers, and pharmacy benefit managers (including the top 25 drugs generating the highest rebate amounts) is intended to assist the Departments understand and report on prescription drug costs, and how they fluctuate over time. 'Life-saving prescription drugs should not cost anyone their life savings," said HHS Secretary Xavier Becerra. Secretary Becerra further stated that, 'Today the Biden-Harris Administration is taking additional steps to make health care more accessible and affordable for patients. By collecting key data on the costs of prescription drugs, we are promoting competition and transparency in the health care industry as we continue to curb the rising costs of drugs and surprise medical bills." 'With today's rule, we're taking more steps to make sure that the care people receive is affordable," said CMS Administrator Chiquita Brooks-LaSure. Administrator Brooks-LaSure also stated that, 'Expanding on our earlier efforts to implement the No Surprises Act, we will monitor pricing and premium trends to better identify barriers to the low-cost, comprehensive, and person-centered care we all deserve." The new data submission requirements will apply starting with data from the 2020 calendar year. However, the Departments are deferring enforcement of the new requirements until December 27, 2022, to give regulated entities time to come into compliance. This means that the required information for 2020 and 2021 is due by December 27, 2022, although it may be submitted sooner. The Departments anticipate releasing their first report in June 2023 and biennially thereafter. Today's interim final rule with request for comments, 'Prescription Drug and Health Care Spending," implements Title II (Transparency) of Division BB of the CAA, and builds on earlier progress with implementing Title | (the 'No Surprises Act') of Division BB of the CAA. This includes two earlier interim final rules (published on July 13, 2021 and October 7, 2021, respectively) and a notice of proposed rulemaking (published on September 16, 2021). IFN15] Specifically, the rule requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including: ¢ General information regarding the plan or coverage; ¢ Enrollment and premium information, including average monthly premiums paid by employees versus employers; ¢ Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers; ¢ The 50 most frequently dispensed brand prescription drugs; ¢ The 50 costliest prescription drugs by total annual spending; ¢ The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year; ¢ Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and ¢ The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs. [FN16] Michigan Governor Signs Three Bills Aimed At Reducing Prescription Drug Costs For Consumers Michigan Governor Gretchen Whitmer recently signed House Bills 4348, 4351, and 4352, all of which are intended to lower the costs of prescription drugs for residents, ensure that pharmacists can provide honest advice to patients about treatment options, and hold pharmacy benefit managers accountable. 'lam proud to sign this bipartisan legislation that helps us lower the cost of prescription drugs,' noted Governor Whitmer. 'For too long, unlicensed pharmacy benefit managers have been able to engage in practices that drive up costs for Michiganders whose lives and health depend on critical prescription drugs like insulin. This bill brings much-needed transparency to our healthcare system and is a testament to what we can do when we put Michiganders first. | am grateful for the work of my Prescription Drug Task Force for their recommendations and our legislative partners who joined with us to get this done.' House Bill 4348 provides for the licensure of pharmacy benefit managers (PBMs) in Michigan by the Department of Insurance and Financial Services (DIFS). According to a press release from the governor, the legislation: * Helps make necessary medications affordable for Michigan families, ¢ Prohibits PBMs from practicing 'spread pricing' in which PBMs drive up costs when reimbursing pharmacists for prescription drugs, ¢ Prohibits PBMs from forcing pharmacists to sign 'gag clauses' so that pharmacists can communicate openly and honestly with patients about options, ¢ Charges DIFS with the responsibility to regulate PBMs licenses, and THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -10- « Requires PBMs to file transparency reports with DIFS to ensure Michiganders have access to information about the backend cost and profits of the medications they are prescribed. House Bill 4351 prohibits a pharmacy benefit manager (PBM) or carrier from: ¢ Requiring a patient to pay a co-pay that is higher than the selling cost of the drug dispensed to him or her, ¢ Excluding or discriminating against a pharmacy solely because the carrier does not have a vested financial interest in the pharmacy, or ¢ Discriminating against 340B Program entities - the 340 Program is a federal program that provides medication to Medicaid patients at a discount. House Bill 4351 also designates PBMs and health insurance carriers third party administrators (TPA), requiring them to maintain a certificate of authority and follow TPA conduct requirements. House Bill 4352: * Allows pharmacists to provide the current selling price of a drug the pharmacy dispenses or comparative current selling prices of generic and brand name drugs it dispenses without being asked. ¢ Prohibits pharmacies or pharmacists from agreeing to a contract that: o Prohibits disclosure of drug prices and comparative selling prices of generic and brand name drugs, o Violates the provisions of HB 4351 relating to 340B entities and carrier prohibitions, or o Prevents or interferes with a patient's right to receive an eligible drug from a 340B entity. Rick Keyes, Meijer President & CEO, commented on the legislation. Mr. Keyes stated that, 'Meijer cares about the communities we serve and are proud to support this legislation, which will help lower the costs of quality medications for our 2.2 million Michigan pharmacy customers.' Keyes also noted that, 'Our 2,200 Michigan Pharmacy team members work hard to serve these customers, from dispensing 18 million prescriptions to administering 1.8 million COVID-19 vaccines throughout Michigan. This bill makes pricing practices fairer, increases transparency, and helps our customers afford the medications they need to live healthy lives.' The bills are based on recommendations by Governor Whitmer's Prescription Drugs Task Force. The Task Force worked with health policy experts, bipartisan members of the legislature, and stakeholders to discuss solutions to lower the costs of prescription medications for Michigan families. The governor's 2022 State of the State address included proposals to work with the legislature and Attorney General Dana Nessel to hold drug companies accountable, lower the cost of insulin for Michigan families, and save lives. The governor contends that House Bill 4348 will lower the costs of prescription drugs for Michigan families and help Michiganders afford medication, including insulin. Attorney General Nessel currently has an ongoing investigation into the practices of one of the three largest drug manufacturers in the United States and is seeking to use the Michigan Consumer Protection Act to investigate the role of drug companies in raising prices. A bipartisan bill in the legislature would cap insulin prices at $50 a month. [FN17] New Jersey Governor And Members Of State Legislature Introduce Bills Aimed To Reduce Prescription Costs New Jersey Governor Phil Murphy, Senator Troy Singleton, Senator Vitale, Senator Pou, and Assemblyman John McKeon recently announced their support for a legislative package to make prescription drugs more affordable. Together, the four bills are intended to advance prescription drug affordability and price transparency by: (1) capping out-of-pocket costs for insulin, asthma inhalers, and EpiPens; (2) allowing the State to join a multi-state purchasing pool to negotiate for more competitive Medicaid drug prices; (3) establishing oversight mechanisms of Pharmacy Benefit Managers (PBM) while prohibiting certain business and pricing practices; and (4) setting up comprehensive transparency efforts for pharmaceutical manufacturers, PBMs, wholesale drug distributors, and insurance carriers. Transparency measures are included to shed light on cost drivers, trends and other factors related to high prescription drug prices across the prescription drug supply chain and support competitive action across the market. The Governor claims that this legislative package reaffirms his commitment to making high-quality health care more affordable and more accessible to all New Jerseyans. The Governor also reiterated that income limits for the Pharmaceutical Assistance to the Aged and Disabled (PAAD) and the Senior Gold Prescription Discount prescription drug assistance programs have increased by $10,000 for this year, making drug prices more affordable and benefitting over 20,000 seniors. 'As | highlighted in my State of the State address just a few weeks ago, | am deeply committed to making high-quality health care more affordable for all New Jerseyans," said Governor Murphy. Governor Murphy also stated that, 'We have made strong strides over the past four years to put health care back within reach of many, but we must continue to find new ways to save consumers money on health care. From the lifesaving medications to the pills millions of THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -11- consumers take every day to maintain their health, lowering the cost of prescription drugs is a critical component of our broader health care affordability efforts, and today we are taking a major step forward for both short and long-term affordability. | am honored to work with our partners in the Legislature to advance health care affordability for New Jersey's families and seniors." The Governor, Senator Singleton, Senator Vitale, Senator Pou, and Assemblyman McKeon introduced the following bills: * $1614 (Vitale/Pou/Singleton) Requires health insurance carriers to provide coverage for epinephrine auto-injector devices and asthma inhalers; limits cost sharing for health insurance coverage of insulin. ¢ $1615 (Singleton/Vitale/Pou) Establishes certain data reporting requirements for prescription drug supply chain; requires Division of Consumer Affairs to issue annual report on emerging trends in prescription drug pricing; appropriates $900,000. ¢ $1616 (Vitale/Singleton/Pou) Establishes new transparency standards for pharmacy benefits manager business practices. The Governor is also seeking a fourth bill to provide for expedited procurement by the State of a vendor to manage the operations of a Medicaid Multi-State Pooling Supplemental Rebate Arrangement program and associated uniform Preferred Drug List for the NJ FamilyCare program. Senator Joe Vitale, Chair, Senate Health Committee, commented on the proposed laws. He noted that, 'Countless New Jerseyans struggle to afford the expense of prescription medicine, especially senior citizens, low income families and individuals, and those who live with chronic health conditions." Senator Vitale also stated that, 'We continue to make great strides in developing medications that can save lives and treat illnesses, but they are of no use if they are unaffordable. They shouldn't be forced to choose between expensive medicines and paying for other basic needs, and they shouldn't be put in the position of skipping doses to stretch their prescriptions. These bills will bring more transparency and accountability to the drug pricing and distribution process, which will improve access and affordability for consumers. They also go a long way in limiting consumers' exposure to fluctuations in the cost of maintenance drugs, like insulin, that for many are the difference between life and death. | will continue to work with the Governor, my legislative colleagues and health care advocates to bring down prescription drug costs so they are more affordable to those in need." 'As in other aspects of society, the COVID-19 crisis has exposed long-standing disparities in both access to affordable health coverage as well as the ability to obtain prescription drugs among our under-served, low-income and minority communities," said Senator Nellie Pou. Pou also observed that, 'We must find new ways to make health care costs more transparent, and to make prescription drugs affordable for all residents. No one in New Jersey should have to make a choice between buying medicine for a sick child and paying their household bills.* *"®! Democratic House Leaders Introduce Legislative Packages Targeting Practices That Keep Drug Prices High Rep. Carolyn B. Maloney, Chairwoman of the House Committee on Oversight and Reform, Sen. Debbie Stabenow, Chairwoman of Senate Finance Subcommittee on Health Care, as well as their colleagues, recently introduced a package of legislation targeting business practices pharmaceutical companies use to allegedly suppress competition, maintain market monopolies, and keep drug prices high. The legislative reforms follow the Oversight Committee's three-year investigation into pharmaceutical pricing and business practices that exposed pharmaceutical company practices that suppress competition from lower-priced generics and biosimilars and make drug prices unaffordable for many Americans. 'In 2022, no one should be making the hard choice of paying for needed medications or paying the rent. Unfortunately, one in four Americans has trouble affording their medications," said Chairwoman Maloney. 'In my Committee's investigation, we found that Big Pharma manipulates our health care system to suppress competition and increase profits. These three bills target Big Pharma's manipulative practices in order to strengthen competition, promote innovation, and increase transparency into research and development costs-all of which will help make drugs more affordable." 'The House Oversight Committee and | have partnered for years to expose how the American people are being ripped off by drug companies who use taxpayer-funded research to develop lifesaving prescription drugs. We have seen how these drug companies then turn around and charge exorbitant prices for these drugs when people need them the most, without ever having to disclose what they actually spend on research and development. Today, Chairwoman Maloney, Senator Smith and | are introducing new bills to finally put an end to these practices," said Sen. Stabenow. The three bills are intended to promote innovation, enhance transparency in research and development (R&D) spending, and prevent an anti-competitive practice that suppresses generic competition. The Discounted Drugs for Clinical Trials Act amends the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to expensive drugs or biologic products for research purposes at a price no higher than the cost to manufacture. These changes are intended to make pharmaceutical research less expensive and promote innovation. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -12- The Oversight Committee's investigation uncovered evidence that drug companies seek to use the high price of their products to impede the clinical trials of potential competitors. The Pharmaceutical Research and Transparency Act of 2022 amends the Public Health Service Act and the Security Exchange Act to increase public transparency into the costs of clinical trials, which pharmaceutical companies do not currently disclose. The bill would create a publicly accessible repository of cost data for drug clinical trials and requires responsible parties to submit this cost data within a year of trial completion. The bill would also require drug manufacturers to report disaggregated clinical trial costs in their annual securities filings. The legislation would further provide data on companies' investments in innovation and enable evaluation of pharmaceutical industry claims about R&D. The Oversight Committee's investigation revealed that drug companies spend more to enrich shareholders and executives than they do on R&D. The Generic Substitution Non-Interference Act aims to block an anticompetitive practice used by some brand-name pharmaceutical companies, called 'Dispense-As-Written" campaigns, that suppresses the uptake of lower-cost generic or biologic drugs, and leads to increased health care spending. The bill makes it an unfair method of competition for a pharmaceutical company to direct or provide an item or service for the purpose of aiding or assisting a health care provider to write 'dispense as written" when a generic or biosimilar is available. The Oversight Committee's investigation uncovered evidence that pharmaceutical companies use DAW campaigns to preserve their market monopoly for high-priced drugs. 'There is no good reason Americans should be paying more than any country in the world for their prescription drugs." said Sen. Smith. 'This bill would prevent large pharmaceutical companies from using anti-competitive tactics that keep prices high for families struggling to pay for life saving drugs. | will keep pushing to make sure this commonsense legislation gets across the finish line." 'Families in Vermont and across the United States struggle to afford their prescriptions as Big Pharma continues to manipulate the market to make more money," said Rep. Welch. 'These bills all work to curb the pharmaceutical industry's exploitative pricing and reduce costs for families. | appreciate the work done by the Oversight Committee and my colleagues, all of whom agree that Big Pharma's price gouging needs to end. We will continue to keep the pressure up to make sure that no American goes without the life- saving medication they need because of a price they cannot afford.' [FN19] New York Governor Announces Department Of Financial Services Program To Oversee PBMs New York Governor Kathy Hochul recently announced a program intended to bring oversight to Pharmacy Benefit Managers with the creation of the Department of Financial Services' (DFS) Pharmacy Benefits Bureau. Pharmacy Benefit Managers (PBM) are intermediaries in the prescription drug supply chain that have, according to a press release from Hochul's office, 'without regulatory oversight, long controlled the price of drugs for health plans and reimbursement rates for pharmacies." The new bureau will license and supervise the PBM industry, and will monitor its impact on consumers and the cost of health care. 'As we continue our comeback from the COVID-19 pandemic, it's crucial that we take every opportunity to improve the health care system and reduce costs for New Yorkers,' Governor Hochul said. Hochul also stated that, 'This landmark regulatory body will provide careful oversight to protect consumers from predatory practices in the largely unregulated Pharmacy Benefits Managers industry. My administration remains committed to doing everything in its power to reduce the burden of health insurance and prescription drug costs on New Yorkers.' Earlier this year, Governor Hochul signed into law what she contends is the most comprehensive regulatory regime for Pharmacy Benefit Managers (PBMs) in the country, assigning DFS new authority to license and supervise the industry. The New York DFS now has the power to address the 'widely reported problematic practices" in the PBM industry. This program is intended to help lower drug and health insurance costs, protect New Yorkers accessing those drugs, and support New York's pharmacies, many of which are independent small businesses. Furthermore, with the passage of the enacted 2023 State Budget, Governor Hochul secured a $5 million appropriation to fund and staff the new bureau. As the program fully develops, costs to administer this initiative will be offset through the application of fees, assessments, and penalties directly on the PBM industry. This move is intended to ensure that the cost of regulating this industry will fall on the PBMs, not on the taxpayers. In addition to the regulation of PBMs, DFS' existing authority to investigate drug price spikes now falls under the supervision of the new Pharmacy Benefits Bureau. DFS will continue to review reporting, monitor the market conduct, and ensure proper enforcement of consumer protections in New York. Superintendent of Financial Services Adrienne A. Harris stated that, 'The health and wellness of New Yorkers depends on having access to fairly priced prescription drugs. With regulatory oversight of the Pharmacy Benefits Industry, DFS will increase transparency and accountability across the industry, ultimately putting more money in New Yorkers' pockets.' THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -13- New York State Health Commissioner Dr. Mary T. Bassett also commented, noting that, 'Rising prescription drug prices not only increase the cost of healthcare for all New Yorkers, but place a particular burden on the elderly and exacerbate the systemic inequities in healthcare delivery. DOH and DFS will work in concert to promote transparency, preserve access, and curb the rising cost of prescription drug prices for the most vulnerable.' DFS has met with external stakeholders in preparation for the registration deadlines. DFS reminds all PBMs of their requirement to register with the Bureau by June 1, 2022 and to submit their first annual report by July 1, 2022. The bureau has released guidance on both registration and the annual report on the DFS website. DFS will soon file regulatory amendments reflecting the creation of this Bureau. More information will be available in the State Register. State Senator Neil D. Breslin noted that, 'The PBM industry had gone unregulated for long enough. PBMs, both here in New York and across the country, have been taking advantage of the lack of transparency at the expense of patients' well-being. | applaud Governor Hochul, Superintendent Harris and Commissioner Bassett for moving the regulatory process forward ensuring that PBMs are held to a standard of excellence.' Moreover, Assemblymember Richard Gottfried observed that, 'PBMs are widely recognized as major players in driving up drug costs while profiteering at the expense of patients and pharmacists. They've been a black box operating in secret without effective regulation, and PBM mistreatment of independent pharmacists is getting worse as health plans merge with chain pharmacies. This law will provide effective regulation of PBMs and | commend the Governor, Commissioner Bassett and Superintendent Harris for moving forward with timely implementation.' [FN20] Senators Introduce Bipartisan Bill Regulating Pharmacy Benefit Managers; Targets Unfair Pricing Senators Chuck Grassley (R-lowa), ranking member of the Judiciary Committee, and Maria Cantwell (D-Wash.), chair of the Committee on Commerce, Science and Transportation, have introduced bipartisan legislation that would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that the senators claim drive up the costs of prescription drugs at the expense of consumers. The Pharmacy Benefit Manager Transparency Act of 2022 would ban deceptive unfair pricing schemes, prohibit arbitrary claw backs of payments made to pharmacies, and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees. Senator Grassley noted that, 'I hear stories about rising drug costs all the time at my 99 county meetings, and middlemen pocketing consumer and taxpayer money is a big reason for those high costs." Grassley also stated that, 'Pharmacy benefit managers and other intermediaries in the pharmaceutical supply chain must be held accountable for increasing the cost of health care in the United States. It is critical for Congress to direct the Federal Trade Commission to go after these arbitrary, unfair and deceptive practices while also establishing more transparency and accountability." Senator Cantwell also commented on the legislation, observing that, 'The increasing cost of prescription drugs has a devastating effect on the pocketbooks of American consumers. PBMs are the middlemen in the prescription drug supply chain and it's time for Congress to give the FTC the ability to shine a brighter light on any deceptive and abusive practices." PBMs were initially formed in the 1960s to process claims and negotiate lower drug prices with drug makers. PBMs now administer prescription drug plans for hundreds of millions of Americans. Three PBMs control nearly 80 percent of the prescription drug market. They serve as middlemen, managing every aspect of the prescription drug benefits process for health insurance companies, self-insured employers, unions, and government programs. According to a press release from Senator Grassley, PBMs operate out of the view of regulators and consumers in setting prescription costs, deciding what drugs are covered by insurance plans and how they are dispensed. They also enjoy large profits 'that might otherwise be passed along as savings to consumers and undercutting local independent pharmacies." Grassley's press release also argues that this lack of transparency makes it difficult to fully understand if and how PBMs might be manipulating the prescription drug market to increase profits and drive-up drug costs for consumers. Some PBMs have been known to engage in 'spread pricing" in which a PBM charges a health insurance plan more to process a prescription than it reimburses the pharmacy, keeping the difference, which is referred to as the spread. For example, when a pharmacist fills a prescription, a PBM handles the process and informs the pharmacy it will be reimbursed $90. The PBM then charges the health insurance plan $100 for processing the same prescription. The spread of $10 is kept by the PBMs. In some cases, the pharmacy is reimbursed below its cost, driving independent pharmacies out of business, creating pharmacy deserts, and increasing costs for health plans that can result in higher premiums. PBMs can also practice unfair claw backs, retroactively rescinding reimbursement payments made to pharmacies based on arbitrary guidelines and evaluations. Specifically, the legislation: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -14- ¢ Prohibits arbitrary, unfair or deceptive practices: Prohibits PBMs from engaging in spread pricing; arbitrarily, unfairly or deceptively reducing or clawing back drug reimbursement payments to pharmacies; and unfairly charging pharmacies more to offset federal reimbursement changes; ¢ Incentivizes fair and transparent PBM practices: Provides exceptions to liability for PBMs that pass along 100 percent of rebates to health plans or payers and fully disclose prescription drug rebates, costs, prices, reimbursements, fees and other information to health plans, payers, pharmacies and federal agencies; ¢ Improves transparency and competition: Requires PBMs to report the amount of money they obtain from spread pricing, pharmacy fees and claw backs; report any differences in the PBMs' reimbursement rates or fees PBMs charge affiliated pharmacies and non- affiliated pharmacies; report whether and why they move drugs in formulary tiers to increase costs; and it directs the FTC to report to Congress its enforcement activities and whether PBMs engage in unfair or deceptive formulary design or placement; and ¢ Enhances enforcement: Authorizes the FTC and state attorneys general to enforce the legislation and hold bad actors accountable. Grassley and Cantwell's bipartisan proposal is supported by the National Community Pharmacists Association, Community Oncology Alliance, Biotechnology Innovation Organization, and American Pharmacy Cooperative. [FN21] FTC Announces Inquiry Into Prescription Drug Middleman Industry, Focusing On PBMs On June 7, 2022, the Federal Trade Commission (FTC) announced that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers (PBMs) to provide information and records regarding their business practices. The agency's inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. 'Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system," said Federal Trade Commission Chair Lina M. Khan. 'This study will shine a light on these companies' practices and their impact on pharmacies, payers, doctors, and patients." The Commission's inquiry will examine pharmacy benefit managers' role at the center of the U.S. pharmaceutical system. Pharmacy benefit managers are the middlemen who are hired to negotiate rebates and fees with drug manufacturers, create drug formularies and surrounding policies, and reimburse pharmacies for patients' prescriptions. According to the FTC, the largest pharmacy benefits managers are now vertically integrated with the largest health insurance companies and wholly owned mail order and specialty pharmacies. In these roles, pharmacy benefit managers often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter. Many of these functions depend on highly complicated, opaque contractual relationships that are difficult or impossible to understand for patients and independent businesses across the prescription drug system. The inquiry will be examining several practices that have drawn scrutiny in recent years, including: ¢ fees and clawbacks charged to unaffiliated pharmacies; * methods to steer patients towards pharmacy benefit manager-owned pharmacies; * potentially unfair audits of independent pharmacies; * complicated and opaque methods to determine pharmacy reimbursement; ¢ the prevalence of prior authorizations and other administrative restrictions; * the use of specialty drug lists and surrounding specialty drug policies; * the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients. The FTC's inquiry intends to build on the existing public record developed in response to the request for information about pharmacy benefits managers that the agency launched on Feb. 24, 2022. The agency has received more than 24,000 public comments to date. The FTC is issuing the orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies without a specific law enforcement purpose. The companies will have 90 days from the date they receive the order to respond. The Commission voted 5-0 to issue the Section 6(b) orders and conduct the study of pharmacy benefits managers' business practices. Chair Lina M. Khan, Commissioner Rebecca Kelly Slaughter, and Commissioner Alvaro Bedoya issued statements. Commissioners Noah Joshua Phillips and Christine S. Wilson issued a joint statement. IFN22] Senator Chuck Grassley (R-lowa) recently issued a statement after the FTC announced its inquiry, noting that, 'I commend the FTC for taking this step toward a more transparent and understandable prescription drug market. PBMs clearly play an enormous role in what Americans pay for their medicine, and much of that role is opaque and inscrutable. That's why | asked for this study. | know from my THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -15- own investigations that PBMs exercise a significant influence over the prices people pay for insulin at the pharmacy counter, and some business practices create perverse incentives for increases in that price." Senator Grassley also stated that, 'I will be closely watching and reading as the FTC makes progress in this investigation, and am glad the commission heard my request and the clear public demand for transparency." Grassley is a senior member and former chairman of the Senate Finance Committee, and recently asked the FTC to review the role of PBMs in the prescription drug prices, specifically insulin. He also requested FTC assessments in August 2018, and he has introduced legislation to require such a study in multiple successive Congresses. As chairman of the Senate Finance Committee, Grassley and then-Ranking Member Ron Wyden (D-Ore.) called five PBM executives to testify before the committee in 2019. IFN23] FDA Issues Proposed Rule To Increase Consumer Access To Nonprescription Drugs The U.S. Food and Drug Administration (FDA) recently issued a proposed rule titled 'Nonprescription Drug Product with an Additional Condition for Nonprescription Use," which is intended to broaden the range of marketed nonprescription drugs available to consumers. 'Nonprescription drug products play a vital role in America's healthcare system, as millions of people use them to self-manage health conditions every day," said FDA Commissioner Robert M. Califf, M.D. 'As part of the FDA's ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as nonprescription-increasing availability of drugs that would otherwise only be available by prescription." Nonprescription drug products are used by consumers without the supervision of a health care professional and require the ability of the consumer to determine that they have the condition for which the drug is to be used, and to appropriately use the drug. According to the FDA, consumers are likely familiar with the 'Drug Facts Labeling" on nonprescription drug packaging as the primary source for information about a product's intended use, directions for use, and important safety information, all designed in understandable language that is tested for consumer comprehension. The proposed rule, if finalized, would expand options for consumers by establishing the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use. Under the proposed rule, when the FDA finds that labeling alone is insufficient to ensure that the consumer can appropriately self- select and use a drug product in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product. An additional condition for nonprescription use is one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers of the nonprescription drug product. For example, an applicant could propose an additional condition for nonprescription use that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a phone 'app" or an automated telephone response system in order to purchase the nonprescription drug product. Under the proposed rule, if the FDA finds that the additional condition for nonprescription use will permit appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of a healthcare practitioner, it may approve the product for nonprescription use with the additional condition for nonprescription use. As with all proposals, the safety of patients remains a top priority. The FDA encourages public comment for this proposed rule. The comment period will end 120 days after the date of publication in the Federal Register. After the comment period closes, the FDA will review and consider comments as it develops the final rule. The timing of the final rule will depend on the number and substance of the comments. [FN24] Florida Governor Signs Executive Order Requiring More Transparency For PBMs Florida Governor Ron DeSantis recently issued Executive Order 22-164 in an effort to increase transparency in prescription costs for Floridians. This order attempts to hold Pharmacy Benefits Managers (PBMs) accountable when managing prescription drug benefits for insurance companies. 'Florida continues to lead the nation in ensuring accountability in the health care industry and in introducing reforms to combat rising prescriptions costs," said Governor Ron DeSantis. "This executive order requires accountability and transparency for pharmaceutical middlemen when doing business with the state, thereby reducing the upward pressure on prescription drug costs." 'For far too long leaders have chosen the path of inaction, rather than action, and fallen victim to a pharmaceutical system driven by drug companies rather than consumers," said Agency for Health Care Administration Secretary Simone Marstiller. 'Fortunately, Governor DeSantis leads with principle, always putting Floridians first and today's actions will further this commitment by providing insight into the FDA's review process and all agency health care contracts through the end of the decade." The Executive Order directs all executive agencies to include the following provisions in all future contracts and solicitations with PBMs: ¢ Prohibit spread pricing for all PBMs; THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -16- ¢ Prohibit reimbursement clawbacks for all PBMs; ¢ Directs agencies to include data transparency and reporting requirements, including a review of all rebates, payments, and relationships between pharmacies, insurers, and manufacturers; and * Directs all impacted agencies to amend all contracts to the extent feasible with these same provisions. [FN25] Federal Agencies Issue Guidance Regarding No Cost Prescription Birth Control Coverage Following President Biden's Executive Order on ensuring access to reproductive health care, the U.S. Department of Health and Human Services (HHS), alongside the Departments of Labor and of the Treasury (Departments), took action to clarify protections for birth control coverage under the Affordable Care Act (ACA). Under the ACA, most private health plans are required to provide birth control and family planning counseling at no additional cost. The guidance is part of HHS' mission to bolster family planning services, including access to emergency contraceptives. According to a report released by HHS, in 2020, 58 million women benefited from the ACA's preventive services and birth control coverage, which has saved billions of dollars in out-of-pocket spending on contraceptives since the ACA was passed. In response to increasing complaints from women and covered dependents about not receiving this coverage, the Departments issued guidance to remind plans and issuers of the ACA's contraceptive coverage requirements and emphasize the Departments' commitment to enforcement. This announcement is part of a comprehensive effort by the Biden-Harris Administration to protect women's access to reproductive health care. 'Under the ACA, you have the right to free birth control - no matter what state you live in," said HHS Secretary Xavier Becerra. 'With abortion care under attack, it is critical that we ensure birth control is accessible nationwide, and that employers and insurers follow the law and provide coverage for it with no additional cost. Family planning, one of the greatest public health achievements of the 20th century, is key to better health outcomes. We will do all we can at HHS to protect family planning and all other forms of reproductive health care, including abortion care, because it is essential health care." 'Today's guidance makes clear that the law requires group health plans and health insurance issuers to provide contraceptive coverage - including emergency contraception - at no cost to participants," said Labor Secretary Marty Walsh. 'We have heard troubling reports that plans and issuers are not following the law. We expect them to remove impermissible barriers and ensure individuals have access to the contraceptive coverage they need. If plans and issuers are not complying with the law, we will take enforcement action to ensure that participants receive this coverage, again with no cost sharing." 'To the American people, including those who are concerned that their access to care is at risk, | say this: we stand firmly with you, and the Centers for Medicare & Medicaid Services (CMS) will do everything we can to ensure that you have access to the full range of reproductive health care you need," said CMS Administrator Chiquita Brooks-LaSure. 'Today, we are taking another important step by reminding employer-sponsored health plans and health insurance issuers of their obligations to provide the full range of contraceptive care to their enrollees." The ACA guarantees coverage of women's preventive services, including free birth control and contraceptive counseling, for all individuals and covered dependents with reproductive capacity. This includes, but is not limited to: ¢ Hormonal methods, like birth control pills and vaginal rings. ¢ Implanted devices, like intrauterine devices (IUDs). « Emergency contraception, like Plan B? and ella?. ¢ Barrier methods, like diaphragms and sponges. ¢ Patient education and counseling. ¢ Sterilization procedures. ¢ Any additional contraceptives approved, granted, or cleared by the FDA. Last month, HHS Secretary Xavier Becerra, Labor Secretary Marty Walsh, and Treasury Secretary Janet L. Yellen sent a letter to health insurers and employer health plan organizations, and the Departments convened a meeting with them, calling on the industry to commit to meeting their obligations to provide coverage for contraceptive services at no cost as required by the ACA. Below is a list of actions HHS has taken in the days following the Supreme Court's Dobbs ruling to ensure access to reproductive health care: ¢ Launched the ReproductiveRights.gov public awareness website, which includes a know-your-rights patient fact sheet. ¢ Met with Maine Governor Janet Mills, Michigan Governor Gretchen Whitmer, and Oregon Governor Kate Brown, as well as state attorneys general (in Colorado, Minnesota, New York, and Oregon), to discuss state-specific concerns. « Convened a meeting with health insurers and sent them a letter, calling on the industry to commit to meeting their obligations to provide coverage for contraceptive items and services at no cost as required by the ACA. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -17- ¢ Issued guidance to patients and providers that clarifies the extent to which federal law and regulations protect individuals' private medical information when seeking abortion and other forms of reproductive health care, as well as when using health information apps on smartphones. ¢ Announced nearly $3 million in new funding to bolster training and technical assistance for the nationwide network of Title X family planning providers. * Issued guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA) reaffirming that it protects providers when offering legally-mandated, life- or health-saving abortion services as stabilizing care for emergency medical conditions. ¢ Issued guidance to roughly 60,000 U.S. retail pharmacies, clarifying their obligations under federal civil rights laws. ¢ Issued a proposed rule that would strengthen the nondiscrimination provision of the Affordable Care Act and would again make clear that discrimination on the basis of sex includes discrimination on the basis of pregnancy or related conditions, including 'pregnancy termination." HHS claims that it is committed 'to providing accurate and up-to-date information about access to and coverage of reproductive health care and resources." N26] Florida Files Lawsuit Over FDA Delay In Approving State Plan To Import Canadian Drugs Florida Governor Ron DeSantis recently announced a lawsuit against the U.S. Food and Drug Administration (FDA) in response to their 'unreasonable delay" of more than 630 days in approving Florida's proposal for its Canadian Prescription Drug Importation Program. The Agency for Health Care Administration (AHCA) submitted its plan to import cheaper drugs from Canada to the FDA nearly 21 months ago, and they are still waiting for approval from the federal government. 'Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years," said Governor Ron DeSantis. 'The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation. Florida is confident in our importation model, and we continue to look for more ways to lower drug costs for Floridians while the FDA delays approval of this importation proposal." Florida Attorney General Ashley Moody also commented on the lawsuit, noting that, 'Governor DeSantis and | are fighting to lower prescription drug costs, but Washington bureaucrats are blocking our efforts. Today, we filed litigation to force the FDA to accept our medication importation proposal. This action will save Florida $150 million a year." 'Thanks to the decisive leadership of Governor DeSantis and his commitment to empowering patients, we will continue to fight for Floridians and the ability to import high-quality prescription drugs from Canada at a significantly lower price," said Agency for Health Care Administration Secretary Simone Marstiller. 'With each passing day, the complacency of the federal government continues to appear to be a ruse to protect the pharmaceutical industry's "power' over patients." 'Governor DeSantis continues to push for action on every front from the Biden Administration," said Surgeon General Dr. Joseph Ladapo. 'The reality is that people cannot wait upwards of two years to improve access to essential prescriptions. Instead, the federal government is dragging their feet when Americans need affordable prescriptions, now more than ever." In July, Governor DeSantis announced that AHCA filed a Freedom of Information Act (FOIA) request to gain insight into the status of their proposal to lower drug costs. To date, the FDA has failed to respond to this FOIA request, resulting in AHCA filing suit earlier this week. In response to federal government inaction, Governor DeSantis granted AHCA authority to negotiate prices for drugs ineligible for importation, such as insulin and epinephrine. This action is intended to reinforce the demand for Florida's Canadian Prescription Drug Importation Program and provide another way to save money for residents of the state. [FN27] © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . 'Mark Cuban Cost Plus Drug Company's Online Pharmacy Launches with Lowest Prices on 100 Lifesaving Prescriptions," January 19, 2022, available at: https:/Awww.prnewswire.com/news-releases/mark-cuban-cost-plus-drug-companys-online-pharmacy-launches-with- lowest-prices-on-100-lifesaving-prescriptions-301463491 .html [FN3] . 'New Report Finds 82% of Patients Still Experience Medication Delays, Despite Healthcare Industry Advancements," February 8, 2022, available at: https:/Awww.pmewswire.com/news-releases/new-report-finds-82-of-patients-still-experience-medication-delays- despite-healthcare-industry-advancements-301477100.html THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -18- [FN4] . "Prescription Drug Spending per Covered Member Grew Much Faster in Individual Health Plans than Large Group Plans," May 5, 2022, available at: https:/Avwww.newswise.com/articles/prescription-drug-spending-per-covered-member-grew-much-faster-in-individual- health-plans-than-large-group-plans [FN5] . Eric M Tichy, PharmD, MBA, BCPS, FCCP, et al., "National trends in prescription drug expenditures and projections for 2022," American Journal of Health-System Pharmacy, April 6, 2022, available at: https://academic.oup.com/ajhp/advance-article-abstract/ doi/10.1093/ajhp/zxac102/6563384 ?redirectedFrom=fulltext&login=false [FN6] . "Navigating High Drug Costs: Study Finds Consumers Want Their Physician To Lead," April 20, 2022, available at: https:// razormetrics.com/2022/04/20/navigating-high-drug-costs-study-finds-consumers-want-their-physician-to-lead/ [FN7] . Jim Hanchett, "Recreational marijuana access reduces demand for prescription drugs," April 18, 2022, available at: https:// news.cornell.edu/stories/2022/04/recreational-marijuana-access-reduces-demand-prescription-drugs [FN8] . "Partnerships mark a significant milestone towards implementing Colorado's Canadian Drug Importation Program," August 18, 2022, available at: https://hcpf.colorado.gov/prescription-drug-importation-partners [FNS] . "Governor Sisolak launches free prescription discount card for all Nevadans," September 22, 2022, available at: https://gov.nv.gov/News/Press/2022/2022-09-22 prescription-discount-card/ [FN10] . 'Capital Blue Cross Teams with Mark Cuban Cost Plus Drug Company to Help Members and Their Communities Save on Medications," available at: https://capbluecross.mediaroom.com/news-releases ?item=122558 [FN11] . 'AllianceRx Walgreens Pharmacy Reduces Annual Patient Prescription Costs by $6 Million," September 22, 2022, available at: https:/Avww.alliancerxwp.com/contents/press-releases/alliancerx-walgreens-pharmacy-re.html [FN12] "Arine and Gemini Health Announce New Collaboration to Optimize Medications While Lowering Prescription Drug Costs for Blue Shield of California Plan Members," October 26, 2022, available at: https:/Awww.prnewswire.com/news-releases/arine-and-gemini- health-announce-new-collaboration-to-optimize-medications-while-lowering-prescription-drug-costs-for-blue-shield-of-california-plan- members-301659075.html [FN13] . 'McKesson Signs Agreement to Acquire Rx Savings Solutions," September 19, 2022, available at: https:/Avwww.mckesson.com/About- McKesson/Newsroom/Press-Releases/2022/McKesson-Signs-Agreement-Acquire-Rx-Savings-Solutions/ [FN14] . "Lilly commits Insulin Value Program, featuring $35 copay card, to suite of affordability solutions for people with diabetes," September 10, 2020, available at: https://investor.lilly.com/news-releases/news-release-details/lilly-commits-insulin-value-program-featuring-35- copay-card [FN15] . "Biden-Harris Administration Improves Transparency and Oversight of Prescription Drug and Medical Costs," November 17, 2021, available at https:/Awww.cms.gov/newsroom/press-releases/biden-harris-administration-improves-transparency-and-oversight- prescription-drug-and-medical-costs [FN16] . "Prescription Drug and Health Care Spending Interim Final Rule with Request for Comments," November 17, 2021, available at: https:/Avww.cms.gov/newsroom/fact-sheets/prescription-drug-and-health-care-spending-interim-final-rule-request-comments THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -19- [FN17] . "Gov. Whitmer Signs Bipartisan Bills to Lower Prescription Drug Costs for Michiganders," February 23, 2022, available at: https:// www. michigan.gov/whitmer/0,9309, 7-387-90499-577805--,00.html [FN18] . "Governor Murphy, Senator Singleton, Senator Vitale, Senator Pou and Assemblyman McKeon Announce Support for Bill Package to Make Prescription Drugs More Affordable," February 14, 2022, available at: https://nj.gov/governor/news/news/562022/ approved/20220214b.shtml [FN19] . "Maloney, Stabenow, and Smith Lead Colleagues in Introducing Bicameral Package of Legislation to Target Abusive Pharmaceutical Business Practices," April 7, 2022, available at: https://oversight.house.gov/news/press-releases/maloney-stabenow-and-smith-lead-colleagues-in-introducing-bicameral-package-of [FN20] . "Governor Hochul Announces New Watchdog Bureau to Tackle Prescription Drug Costs," May 11, 2022, available at: https:// www.governor.ny.gov/news/governor-hochul-announces-new-watchdog-bureau-tackle-prescription-drug-costs [FN21] . "Grassley, Cantwell Introduce Bipartisan Bill To Combat Rising Prescription Drug Prices And Provide More Transparency," May 24,2022, available at: https:/Avww.grassley.senate.gov/news/news-releases/grassley-cantwell-introduce-bipartisan-bill-to-combat-rising- prescription-drug-prices-and-provide-more-transparency [FN22] "Agency to Scrutinize the Impact of Vertically Integrated Pharmacy Benefit Managers on the Access and Affordability of Medicine," June 7, 2022, available at: https://Awww.fic.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen- industry [FN23] . "Following Grassley Requests, FTC Opens Probe Of Prescription Drug Middlemen," June 8, 2022, available at: https:// www.grassley.senate.gov/news/news-releases/following-grassley-requests-fic-opens-probe-of-prescription-drug-middlemen [FN24] . "FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs," June 27, 2022, available at: https:// www.fda.gov/news-events/press-announcements/fda-introduces-innovative-proposal-advance-consumer-access-nonprescription-drugs [FN25] . "Governor Ron DeSantis Takes Additional Actions to Lower Prescription Drug Prices for Floridians," July 8, 2022, available at: https:// www.figov.com/2022/07/08/governor-ron-desantis-takes-additional-actions-to-lower-prescription-drug-prices-for-floridians/ [FN26] . 'HHS, DOL, and Treasury Issue Guidance Regarding Birth Control Coverage," July 28, 2022, available at: https:/Awww.hhs.gov/about/ news/2022/07/28/hhs-dol-treasury-issue-guidance-regarding-birth-control-coverage.html [FN27] . "Governor Ron DeSantis Announces Lawsuit Against Biden Administration's Reckless Delay of Canadian Prescription Drug Importation Program," August 31, 2022, available at: https://Awww.flgov.com/2022/08/31/governor-ron-desantis-announces-lawsuit- against-biden-administrations-reckless-delay-of-canadian-prescription-drug-importation-program/ Produced by Thomson Reuters Accelus Regulatory Intelligence 27-Jun-2023 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -20-